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Quality Assurance Senior Associate

Salary:
45,568 P.A. ?
Location:
Stevenage
Company:
TCR² Therapeutics

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At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage immunotherapy company pioneering the development of novel T cell therapies. Our two lead cell product candidates are being studied in Phase 1/2 trials: TC-210, for solid tumors and TC-110 for hematological malignancies. Our research efforts focus on broadening our pipeline with a series of next-generation enhancements that may further improve clinical outcomes. We are headquartered in Cambridge, Massachusetts and have a clinical manufacturing facility in Stevenage, UK.

TCR2 has embarked on establishing a cGMP manufacturing operation in the UK at Stevenage, Hertfordshire, to provide manufacturing capacity for Phase 1 and Phase 2 operations, and beyond, for the TRuCTM T cell platform. The Quality Assurance Sr. Associate will support the manufacture and release of products under the Quality Management System environment, support product and batch record reviews, investigations into non-compliance, CAPA management, supplier qualification and documentation controls.

Responsibilities:

  • Maintain quality supporting documentation to facilitate GMP production.
  • Perform quality review of manufacturing records.
  • Review Change Control records impacting T cell therapy product.
  • Release documents and labels to the manufacturing production teams.
  • Provide investigational support of potential deviations for the manufacture, testing, and shipping events to and from the UK.
  • Write and revise quality SOPs and associated documentation to support GMP production.
  • Support the quality vendor approval for suppliers, contractors and service providers.
  • Assist in providing training for GMP and GDP processing.
  • Perform deviation review and implementation of CAPA to improve product quality.
  • Liaison with CGT Quality department on quality related issues.

Qualifications and Experience:

  • Bachelor’s degree in the biological sciences or related field.
  • Minimum of 5 years GMP experience in a biotech, or biologics operation, or equivalent education/work experience.
  • Knowledge of Quality Management System elements and experience in maintaining and improving systems supporting the QMS.
  • Prior experience in a quality function (quality assurance or quality control), preferably in a commercial environment.
  • Working knowledge and ability to apply GMPs in conformance with FDA, MHRA, EU and ICH standards, preferably gained from working in a manufacturing or QC environment.
  • Good interpersonal, verbal and written communication skills.
  • Comfortable in a fast-paced small company environment with minimal direction.
  • Internal auditing experience preferred

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